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NCT Number: NCT06831942

Attempted Suicide Short Intervention Program for Older Adults (ASSIP-OA): An Evaluation of a Psychosocial Intervention for Suicidal Adults Aged 65+

Older adults are sorely underrepresented in suicide prevention research, despite the fact that suicide rates are higher in this age group than in any other age group in Sweden and in many countries worldwide. There are extremely few clinical intervention studies that target this age group, with to date no published studies in Europe. The overall aim is to develop and test a modified version of the Attempted Suicide Short Intervention Program (ASSIP), which the investigators will adapt specifically for older adults (65+). The original ASSIP was developed in Switzerland where it has shown an 80% decrease in risk of new suicide attempts compared to ordinary treatment. In Sweden, ASSIP is currently being tested for persons aged 18+ . The investigators now propose a randomised controlled trial (RCT) to evaluate a modification of ASSIP specifically designed to meet the needs of suicidal persons aged 65 and above, the ASSIP-Older Adult program (ASSIP-OA).

Main study questions

1. Compared to treatment as usual (TAU), will the addition of the ASSIP-OA to ordinary treatment have a preventive effect on suicide and suicide attempts within 6, 12, and 24 months following the index episode? 2. Compared to TAU, do ASSIP-OA participants show better improvement in coping skills and psychiatric symptoms a) after the last session and b) at 6-,12- and 24- month follow-up? 3. Is a brief preventive intervention (ASSIP-OA) for older adults feasible, based on its acceptability, appropriateness, deliverability and fidelity? Do participants experience side effects? Do they have fewer days of inpatient care? 4. What kind of challenges and opportunities do a) older adults and b) ASSIP-OA therapists experience in relation to implementing a brief preventive intervention like ASSIP-OA? Are the modifications that the investigators made in ASSIP-OA relevant for older adults?

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Suicide Attempt Suicide, Attempted

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Södra Älvsborg Hospital, Borås, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65 and above at time of index suicide attempt or hospitalisation for serious suicidal plans.
  • A mental health care contact during the active treatment period.
  • Capable of understanding study procedures and providing informed consent.

Exclusion criteria

  • Clinical diagnosis of dementia or MoCa score less than -2 standard deviations from the normative score for education and age (Borland et al., 2017). Ongoing delirium, or any other condition impeding the comprehension of the study's procedures and implications that hinder the provision of informed consent.
  • Severe ongoing psychosis, severe ongoing substance use disorder, emotionally instable personality syndrome and any other condition that would require longer specialized treatment to reduce future suicidal behaviour (e.g. DBT).
  • Terminal illness.
  • Insufficient knowledge of the Swedish language (requires interpreter).
  • Aphasia or other severe communication issue or severe hearing and/or severe visual impairment that render the intervention unfeasible despite corrective aids.

Treatment and study plan

ASSIP-OA

Behavioral

ASSIP-OA + TAU

  • First session. Narrative interview focusing on the background of the suicidal crisis. The patient receives a psychoeducational text to read and comment on as homework.
  • Second session. Video playback. The patient and therapist watch the video recording from session 1 together, periodically pausing the video to comment and add information.
  • Third session. Compilation of a written case conceptualization of the individual's vulnerability and triggering events that preceded the suicidal crisis.
  • Fourth session. An optional extra session to further train safety strategies.
  • Fifth session (optional). Includes one or two close relatives or other support person(s), chosen by the participant. The session focus on how safety measures learned in in ASSIP-OA can be translated into everyday life.
  • Standardized letters. therapists will send standardized letters every third month during the first year and biannually during the second year.

Treatment as usual (TAU)

Other

Antidepressant medication, alone or in combination with other types of psychoactive drugs (sedatives/antipsychotics/hypnotics/mood stabilizers) constitute the cornerstone of treatment for suicidal older adults. Persons with serious depression or treatment-resistant depression may be offered electroconvulsive therapy (ECT). Some persons may receive supportive/therapeutic contacts with mental health professionals (nurses/social workers/psychologists) but no psychosocial interventions designed specifically for suicidal older adults are offered as part of ordinary treatment at the participating clinics.

Primary outcomes

  1. New suicidal episode which includes suicide attempt or death by suicide

    Time frame: Follow-ups at 6, 12 and 24 months

    The primary outcome variable at 6-, 12- and 24-month follow-up is any "new suicidal episode," a composite rating that is coded "yes" in the event of a) a new suicide attempt as registered in the participant's medical record or the national hospital register or b) suicide death as registered in the national cause of death register.

Secondary outcomes

  1. Severity of suicidal ideation

    Time frame: Secondary effect measures will be collected at baseline, immediately after the intervention (for the control group 5 weeks after baseline) and at the 6-, 12- and 24-month follow-ups.

    Columbia-Suicide Severity Rating Scale (C-SSRS) Scores range from 0-5, where higher scores indicate more severe ideation.

  2. Depressive symptoms

    Time frame: Secondary effect measures will be collected at baseline, immediately after the intervention (for the control group 5 weeks after baseline) and at the 6-, 12- and 24-month follow-ups

    Montgomery-Åsberg Depression Rating Scale (MADRS) Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.

  3. Anxiety

    Time frame: Secondary effect measures will be collected at baseline, immediately after the intervention (for the control group 5 weeks after baseline) and at the 6-, 12- and 24-month follow-ups

    Generalized Anxiety Disorder 7-item scale (GAD-7). Each item yields a score of 0 to 3; the overall score thus ranges from 0 to 21. Higher GAD-7 score indicates more severely elevated anxiety.

  4. Coping

    Time frame: Secondary effect measures will be collected at baseline, immediately after the intervention (for the control group 5 weeks after baseline) and at the 6-, 12- and 24-month follow-ups

    Brief - Coping Orientation to Problems Experienced Inventory (Brief-Cope) 28 item scale 1= I haven't been doing this at all 2= A little bit 3 = A medium amount 4= I've been doing this a lot. Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style.

  5. Health-related quality of life

    Time frame: Secondary effect measures will be collected at baseline, immediately after the intervention (for the control group 5 weeks after baseline) and at the 6-, 12- and 24-month follow-ups

    EQ-5D-5L . The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: Each dimension has 5 levels: A higher 1-digit number mean a worse outcome. High scores on the EQ VAS mean a better outcome.

  6. Health-care utilization

    Time frame: 12- and 24-month follow-ups.

    We will assess psychiatric inpatient hospitalizations, as well as the number and type of psychiatric healthcare contacts, based on medical records.

Other outcomes

  1. Therapeutic Alliance

    Time frame: After the second ASSIP-OA session approx 2 weeks after of study inclusion

    Working Alliance Inventory-Short Revised (WAI-SR) measures therapeutic alliance on 12 items on a 7-point Likert scale from 1 = "never" to 7 = "always. "

  2. Side effects

    Time frame: After the last ASSIP-OA session approx 5 weeks after study inclusion

    Negative Effects Questionnaire (NEQ). It contains 32 items that are scored on a five point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances, as well as one open-ended question.

  3. Feasibility measure Acceptability

    Time frame: Post intervention approx after 5 weeks

    Acceptability will be addressed in the qualitative interviews with patients post intervention.

  4. Feasibility measure - Appropriatness

    Time frame: Post intervention (5-weeks) and at follow upp after 6, 12 and 24 months.

    Appropriateness is measured by Cronbach alpha and mean inter-item correlation in our questionnaires.

  5. Feasibility measure - Deliverability

    Time frame: Week 1,2,3,4,5

    Deliverability is measured by examining that all components of the ASSIP- OA are provided on the 3-5 sessions without having to stress through them.

  6. Feasibility measure - Fidelity

    Time frame: Week 1, 2, 3, 4, 5

    To ensure good administration of the ASSIP-OA, the investigators use: (1) training manuals with checklists for the therapists to check after each session, and (2) video recordings of randomly selected ASSIP- OA sessions (15%). They are reviewed by independent assessors using a checklist to rate the therapist's competence and adherence to the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Margda Waern, Professor

CONTACT

[email protected]

Sara Hed, Phd Student

CONTACT

[email protected]

+46735324985

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University

Registry information

Official study title

Attempted Suicide Short Intervention Program for Older Adults (ASSIP-OA): An RCT and a Qualitative Evaluation of a Psychosocial Intervention for Suicidal Adults Aged 65+

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Feb 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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